Daily Disposable Performance of 1•DAY ACUVUE® TruEye™ and 1•DAY ACUVUE® MOIST® With LACREON® TECHNOLOGY
TEMPO
1•DAY ACUVUE® TruEye™ Brand Contact Lenses & 1•DAY ACUVUE® MOIST® Brand Contact Lenses With LACREON® TECHNOLOGY Daily Disposable Performance Overview Registry -TEMPO Study
1 other identifier
observational
1,171
1 country
37
Brief Summary
This study is an observational registry of patients who have recently been prescribed 1•DAY ACUVUE® TruEye® or 1•DAY ACUVUE® MOIST® Brand Contact Lenses with LACREON® TECHNOLOGY.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2011
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 26, 2011
CompletedFirst Posted
Study publicly available on registry
November 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
September 15, 2015
CompletedJune 19, 2018
October 1, 2015
2 years
October 26, 2011
July 1, 2015
June 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Adverse Events
Adverse events were reported by subjects via the electronic surveys if they responded "yes" to the question "Since we last contacted you, have you experienced a red or painful eye that required a visit to an eye doctor or emergency room?". Consensus diagnosis was made after review of clinical records by Adjudication Panel.
Self-report at 2 Week, 4 Month or 12 Month surveys
Secondary Outcomes (1)
Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys
Baseline, 2 Week, 4 Month or 12 Month surveys
Study Arms (2)
1-Day ACUVUE TruEye contact lens users
1-Day ACUVUE TruEye contact lens users
1-Day ACUVUE MOIST contact lens users
1-Day ACUVUE MOIST contact lens users
Interventions
daily disposable soft contact lenses
daily disposable soft contact lenses
Eligibility Criteria
Patients who have recently been fit with 1-Day ACUVUE® TruEye™ or 1- Day ACUVUE® MOIST® daily disposable lenses.
You may qualify if:
- Wearers of 1•DAY ACUVUE® TruEye™ or 1•DAY ACUVUE® MOIST® daily disposable soft contact lenses in both eyes aged \>8 years of age who have recently begun use of that lens type and have purchased at least 3 month supply of lenses.
- The registrant must read and sign the Informed Consent form. Minor subjects must obtain parental signature of Informed Consent and also sign an Informed Assent Form.
- The registrant must sign the Release of Medical Records in the event of an adverse event in the study.
- The registrant must appear able and willing to adhere to the instructions set forth in this clinical protocol.
You may not qualify if:
- Previously wearing the type of lenses with which they are registering (1•DAY ACUVUE® TruEye™ or 1•DAY ACUVUE® MOIST® Daily Disposable lenses).
- Current participant in an unrelated research study.
- Employee or family member of Recruiting Practitioner or Johnson \& Johnson.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Unknown Facility
Campbell, California, 95008, United States
Unknown Facility
Fullerton, California, 92831-1615, United States
Unknown Facility
Huntington Beach, California, 92647, United States
Unknown Facility
Los Angeles, California, 90049, United States
Unknown Facility
Mountain View, California, 94041, United States
Unknown Facility
Newport Beach, California, 92660, United States
Unknown Facility
Salinas, California, 93901, United States
Unknown Facility
San Francisco, California, 94103, United States
Unknown Facility
San Francisco, California, 94111, United States
Unknown Facility
San Francisco, California, 94158, United States
Unknown Facility
San Jose, California, 95131, United States
Unknown Facility
Sunnyvale, California, 94086, United States
Unknown Facility
Washington D.C., District of Columbia, 20016, United States
Unknown Facility
Boca Raton, Florida, 33431-7253, United States
Unknown Facility
Boca Raton, Florida, 33432-3938, United States
Unknown Facility
Fort Lauderdale, Florida, 33316, United States
Unknown Facility
Fort Lauderdale, Florida, 33328-2018, United States
Unknown Facility
North Miami, Florida, 33181, United States
Unknown Facility
Pembroke Pines, Florida, 33024, United States
Unknown Facility
Wellington, Florida, 33414, United States
Unknown Facility
Roswell, Georgia, 30075, United States
Unknown Facility
Des Moines, Iowa, 50310, United States
Unknown Facility
Shreveport, Louisiana, 71105, United States
Unknown Facility
Belmont, Massachusetts, 02478, United States
Unknown Facility
Cambridge, Massachusetts, 02138, United States
Unknown Facility
Dedham, Massachusetts, 02026, United States
Unknown Facility
Lake Hopatcong, New Jersey, 07849, United States
Unknown Facility
New York, New York, 10022, United States
Unknown Facility
New York, New York, 10036, United States
Unknown Facility
Charlotte, North Carolina, 28210, United States
Unknown Facility
Gastonia, North Carolina, 28054, United States
Unknown Facility
Cleveland, Ohio, 43081, United States
Unknown Facility
Johnstown, Ohio, 43031, United States
Unknown Facility
Westerville, Ohio, 43081, United States
Unknown Facility
Brentwood, Tennessee, 37027-7552, United States
Unknown Facility
Amarillo, Texas, 79119, United States
Unknown Facility
Milwaukee, Wisconsin, 53227, United States
Related Publications (2)
Hickson-Curran SB, Chalmers RL, Keay L, Gleason W. Patient-Reported Wearing Experience From Hydrogel Daily Disposable Wearers Older Than 40 Years From the TEMPO Registry. Eye Contact Lens. 2017 Sep;43(5):313-317. doi: 10.1097/ICL.0000000000000271.
PMID: 27243356DERIVEDChalmers RL, Hickson-Curran SB, Keay L, Gleason WJ, Albright R. Rates of adverse events with hydrogel and silicone hydrogel daily disposable lenses in a large postmarket surveillance registry: the TEMPO Registry. Invest Ophthalmol Vis Sci. 2015 Jan 8;56(1):654-63. doi: 10.1167/iovs.14-15582.
PMID: 25574042DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jurandir Araujo
- Organization
- Vistakon
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2011
First Posted
November 8, 2011
Study Start
October 1, 2011
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
June 19, 2018
Results First Posted
September 15, 2015
Record last verified: 2015-10